Risk Management & Inspection Readiness QA Senior

Job Description

<strong>KEY RESPONSIBILITIES AND TASKS:<br><br><br><br><br><br><br></strong><ul><li>Contamination Control Strategy (For Sterile):<br></li><ul><li>Act as the Contamination Control Subject Matter expert for the site.</li><li>Lead and follow Annex 1 project, manage the project implementation plan with different cross functional teams in IA.</li><li>Contamination control strategy leading and ensure its implementation on-site.</li><li>Maintain the Holistic contamination control strategy up-to-date for sterile facility.</li><li>Perform the responsibilities of the contamination control SME.<br></li></ul><li>Quality Risk Management<br></li><ul><li>Execution of quality risk process.</li><li>Follow up implementation of quality risk assessments master plan.</li><li>Act as facilitator for risk assessment process on-site.<br></li></ul><li>Global Quality Documents Gap analysis <br></li><ul><li>Following up the performance of gap analysis for any updated global quality documents and implementation of any raised actions from this gap analysis</li><li>Perform gap analysis for the assigned documents.<br></li></ul><li>Annex 1 Compliance:<br></li><ul><li>Supervising and participation in Annex 1 required gap assessments.</li><li>Performing of required risk assessments.</li><li>Creation of Holistic contamination control strategy. <br></li></ul><li>Participate in Site Self inspection for GMP related areas among all industrial affairs departments<br></li><ul><li>Preparation of an annual plan for internal audit for different departments on yearly basis.</li><li>Participate in Execution of the plan through conducting self-inspection in different departments.</li><li>Creation of self-inspection report within the specified timelines.</li><li>Follow up the creation of the required action plans by the concerned area responsible within the specified timelines.<br></li></ul><li>Inspection Readiness (GRIC, SQRs, Inspections and Audits Management).<br></li><ul><li>Ensure inspection readiness according to the IR Sanofi handbook.</li><li>Create satisfactory action plan for the communicated GRIC memos, SQR reports, and received audits or inspections by the concerned area responsible.<br></li></ul><li>Suppliers and subcontractors’ Audits<br></li><ul><li>Set the annual audit plan for Cairo site.</li><li>Manage the implementation of the plan and follow it’s closure.</li><li>Participate in Suppliers and subcontractors’ audits.</li><li>Documentation of audit reports and follow up of its relevant action plans implementation.<br><br></li></ul></ul><strong>JOB-HOLDER ENTRY REQUIREMENTS</strong><em>:<br><br></em><ul><li>5+ years total experience in Pharmaceutical environment within Quality Assurance/Production.</li><li>Practical experience in risk assessment processes.</li><li>Practical experience for different manufacturing processes regulations.</li><li>Experience in Sterility assurance concepts. “Knowledge of contamination control strategies &amp; Annex 1 requirements is an asset”.<br><br></li></ul><strong>Skills, Experience &amp; Knowledge Requirements<br><br></strong><ul><li>Good communication &amp; Presentation skills.</li><li>Planning &amp; organizing skills</li><li>Problem solving skills.</li><li>Report writing skills.</li><li>Ability to co-ordinate several inter-departmental activities.</li><li>Good command of MS Word, Excel &amp; Power Point.</li><li>Good Manufacturing Practices (GMP) &amp; Good Documentation Practices (GDP).<br><br></li></ul>At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.